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OpenTrials
Completed

NCT Number: NCT03132194

Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.

Completed

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.

Exclusion criteria

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Treatment and study plan

DPSG 7.5%

Drug

topical gel

Other names: dapsone

Aczone

Drug

topical gel

Other names: dapsone

Placebo

Drug

topical gel

Other names: Vehicle

Primary outcomes

  1. Change in inflammatory lesion counts

    Time frame: 12 weeks

    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in non-inflammatory lesion counts

    Time frame: 12 weeks

    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary outcomes

  1. Clinical response of success

    Time frame: 12 weeks

    The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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